Neonatal Opioid Withdrawal Syndrome (NOWS) in Kentucky: Improving Outcomes for Infants

项目摘要/摘要 阿片类药物和其他精神活性药物在育龄妇女中的医疗和非医疗用途是 这在美国是一个重大的公共卫生问题。发育中的胎儿在宫内长期暴露于 母亲的阿片类药物通常会在分娩后导致新生儿阿片类药物戒断综合征(NOWS)。婴儿患有 现在的人可能有轻微的戒断迹象，对他们的功能影响最小，或者他们可能 需要长时间的药物治疗和漫长的新生儿医院的显著戒断 留下来，给家庭、社区和医疗保健系统带来压力。延长住院时间可能会导致 降低母婴的亲和力和依恋，对神经发育和 受影响儿童的行为结果。孕期及以后使用阿片类药物的流行率 在农村和服务不足的地区，分娩后NOWS的发生率高得不成比例。肯塔基州是 高度农村和服务不足的州，估计NOWS的比率大约是 全国平均水平。 尽管这一问题很重要，但新生儿NOWS的临床护理因缺乏而变得复杂 国家认可的标准化方法，这导致了站点到站点之间的重大差异。这样的变化是 部分原因是缺乏可推广的证据来指导临床实践。之前的研究一直受到以下因素的限制 由于招募和保留困难，样本量较小，以及研究设计的固有局限性。 为了找出最有效的治疗方法，从而优化NOWS婴儿的护理，直接 在可推广的人群中比较药物治疗方案是迫切需要的。 与当地社区合作伙伴和其他临床站点的合作将在 建议研究联盟设计、实施和实施一项多中心随机对照临床试验 审判。这项试验的目的是为患有NOWS的婴儿提供直接的药物治疗比较， 说明混淆变量，如非药物护理和辅助药物，并评估 出生后头几年的神经发育和行为结果。这一RCT的预期结果将是 高度可推广，以改善肯塔基州和全国NOWS婴儿的护理。

PROJECT SUMMARY/ABSTRACT The medical and non-medical use of opioids and other psychoactive drugs in women of childbearing age is a significant public health concern in the United States. Prolonged in utero exposure of the developing fetus to maternal opioids often results in Neonatal Opioid Withdrawal Syndrome (NOWS) after delivery. Infants with NOWS may have mild signs of withdrawal that minimally impact their ability to function or they may have significant withdrawal that requires a prolonged course of pharmacologic therapy and a lengthy newborn hospital stay which stresses families, communities, and the healthcare system. Prolonged hospitalization may result in decreased maternal and infant bonding and attachment and have a negative impact on neurodevelopmental and behavioral outcomes of affected children. The prevalence of opioid use during pregnancy and the subsequent occurrence of NOWS after delivery is disproportionately higher in rural and underserved areas. Kentucky is a highly rural and underserved state and has an estimated rate of NOWS that is approximately three times the national average. Despite the significance of this problem, the clinical care for neonates with NOWS is complicated by a lack of nationally accepted standardized approaches which leads to significant site-to-site variation. Such variation is due in part to a lack of generalizable evidence to inform clinical practice. Previous research has been limited by both small sample sizes, due to difficulty with recruitment and retention, and inherent limitations in study designs. In order to identify the most effective treatment and thereby optimize the care of infants with NOWS, a direct comparison of pharmacologic treatment regimens in a generalizable population is urgently needed. Collaboration with local community partners and with other clinical sites will be undertaken within the proposed research consortium to design, implement, and conduct a multicenter randomized controlled clinical trial. The goal of the trial is to provide a direct comparison of pharmacologic treatment for infants with NOWS, account for confounding variables such as non-pharmacologic care and adjuvant medications and evaluate neurodevelopmental and behavioral outcomes in the first years of life. The anticipated results of this RCT will be highly generalizable to improve care for infants with NOWS in KY and throughout the nation.